Assist with preparation of software and design control documentation, ECNs, procedures and specifications.
Ensure compliance to document control requirements.
Manage related activities with documentation archiving, requests and training.
Support activities for process improvements and systems integration.
• Demonstrated knowledge and expertise with Microsoft Word & Excel
• Experience with printers, scanning equipment, and electronic documentation systems ...
Quality Manager #17697
To apply click here: http://vanh.maxhire.net/cp/?E55D6A361D43515B7A5913653A53176C03627E405502
Manages plant quality staff across quality systems and product quality.
Oversees the quality and documentation system and quality records program.
Responsible for execution of Design Verification and Process Validation for site projects.
Manages QMS processes for management review, CAPA, and internal audit.
Manages and provides resources for quality ...
· Guides or supports the creation and filing of appropriate EU/US submissions to ensure in vitro diagnostic devices are commercially available in Europe and/or U.S. Guides regulatory projects, project schedules, and product introduction process.
· Depending on experience, guides the decision making process on regulatory submission issues using historical knowledge, legal counsel and FDA's current regulations on medical device industry.
· Bachelor’s degree in scientific ...
Start: 5/8/2013 End: 11/20/2013
Looking for an experienced general EE type who can hit the ground running and ideally has a background in medical device systems development.
MINIMUM EDUCATION AND YEARS OF EXPERIENCE:
• 7-10 years with Bachelors
• 5-8 years with Masters
• 3-6 years with Doctorate
• BS/MS/PhD Engineering; Electrical, Computer/Software, or Biomedical Engineering with electrical engineering focus ...
Job Title: Agile PLM Systems Analyst
Location: Alameda, CA 94502
Duration: 3-6+ months (Strong possibility for extension)
Job Description / Requirement:
Primary Job Function
• Defines, plans & designs client area application systems requirements for new or modified applications, in the preparation of application system specifications, and in the development, testing, and implementation of efficient, cost effective application solutions.
• Specifically, has comprehensive knowledge ...
Seeking experience with IDE's, PMA's and 510k's to ensure regulatory and ISO 13485 comliance and get regulatory approval for medical devices.
Shall oversee management of manage content, assembly, pre-final review, and filing of medical device applications.
Enjoy the career path opportunities that only a growing company can provide while earning a top salary plus bonuses and full company paid benefits – Medical, dental and a vision plan, prescription drug plan, flexible spending account, short and ...
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